Senile PtosisLIFTNCT03055819
Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study
A study testing Brow Lift in people with Senile Ptosis, run by Zift, LLC at 1 site in United States.
Trial summary
The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a browlift for patients with age-related brow ptosis. It is a single arm, open label multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20 subjects in up to 3 sites will be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Senile Ptosis
- What is being tested?
- Brow Lift
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2017to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide informed consent to the treatment
- Willing and able to participate in all the required follow-ups
- Over 18 years of age
- Under 75 years of age
- Brow ptosis and/or functional limitations such as vision defects due to tissue laxity caused by aging
Who cannot join
- Known allergies to local anesthesia
- Currently undergoing chemotherapy or radiation therapy for cancer
- Known advanced osteoporosis that may lead to skull thinning
- Taking long-term immunosuppressant therapy
- Taking chronic anticoagulation therapy (including ASA and NSAIDS) which can't be stopped for 10 days before treatment.
- Unable or unwilling to participate in follow-up examinations
Show all 14Show fewer
- Evidence of brow soft tissue thickness less than 4mm by physical exam, ultrasound or direct probe (probe at the time of procedure)
- Stroke or TIE (Transient Ischemic Event) within the past 6 months and currently on anti-platelet or other blood thinners
- Chronic facial paralysis due to trauma, Bells Palsy, or similar etiology
- Treatment with neurotoxin in the past 6 months and during the study period. Subjects may undergo a neurotoxin washout for 6 months prior to study participation
- Planned surgical procedures, fillers or other facial procedures during the study period.
- Planned modification of the eyebrows (to include plucking or shaving) during the study period
- Planned MRI during the study period
- Known nickel allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Centennial Lakes Surgery Center
Edina, Minnesota, 55435
About this study
The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a browlift for patients with age-related brow ptosis. It is a single arm, open label multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20 subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used to confirm the device safety and efficacy and provide inputs to further refine the device design and procedure technique for future device iterations
Read the detailed description
The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a browlift for patients with age-related brow ptosis. It is a single arm, open label multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20 subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used to confirm the device safety and efficacy and provide inputs to further refine the device design and procedure technique for future device iterations Subjects with signed informed consents and who meet all the inclusion and none of the exclusion criteria and are treated with the device will be considered enrolled in the study. An interim report will be created after the first 20 patients has completed their 90 follow up and the data monitored. The 20 patients, 90 day report may be submitted to FDA and other agencies for product clearance and registrations. After FDA clearance has been obtained, the study may be converted to a post-market study for the long term follow up.
- Conditions
- Senile Ptosis
- Being tested
- Brow Lift
- Keywords
- Brow Lift, Brow Ptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brow LiftDevice
Also called Brow Pexy
Minimally Invasive Brow Lift
| Study group | Role | What they receive |
|---|---|---|
| ZiftLift Tissue Anchor | Experimental | Use of ZiftLift Tissue Anchors for Brow Lift Receives: Device: Brow Lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brow Elevation
Change in brow elevation in mm from baseline to 90 days, with long term follow-up out to 4 years
Measured: 90 days, 6 months, 1, 2, 3 and 4 years
Secondary outcomes (2)
Patient Satisfaction
Patient Satisfaction using the Face-Q survey
Measured: 90 days, 6 months, 1, 2, 3 and 4 years
Physician Satisfaction
Physician Satisfaction with Cosmetic Result. 7 metrics on all patients at all time points using a survey tool.
Measured: 90 days, 6 months, 1, 2, 3 and 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start3 Feb 2017
- Primary completion2 Apr 2018
- Study completion31 Oct 2018
Why it stopped: Company no longer exists
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Senile PtosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open label, multi-center
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zift, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Libra Medical
- Responsible party
- Sponsor
- Investigators
- Peter A Hilger, MD, Principal investigator, Centennial Lakes Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055819
- Sponsor's protocol ID
- 1068-001Rev3
- Acronym
- LIFT
- Status last verified
- Aug 2023
- First submitted
- 14 Feb 2017
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study
- ClinicalTrials.gov ID
- NCT03055819
- Acronym / sponsor ID
- LIFT / 1068-001Rev3
- Conditions
- Senile Ptosis
- Keywords
- Brow Lift, Brow Ptosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company no longer exists
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zift, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Libra Medical
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a browlift for patients with age-related brow ptosis. It is a single arm, open label multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20 subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used to confirm the device safety and efficacy and provide inputs to further refine the device design and procedure technique for future device iterations
Detailed description
The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a browlift for patients with age-related brow ptosis. It is a single arm, open label multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20 subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used to confirm the device safety and efficacy and provide inputs to further refine the device design and procedure technique for future device iterations Subjects with signed informed consents and who meet all the inclusion and none of the exclusion criteria and are treated with the device will be considered enrolled in the study. An interim report will be created after the first 20 patients has completed their 90 follow up and the data monitored. The 20 patients, 90 day report may be submitted to FDA and other agencies for product clearance and registrations. After FDA clearance has been obtained, the study may be converted to a post-market study for the long term follow up.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open label, multi-center
| Arm | Type | Receives |
|---|---|---|
| ZiftLift Tissue Anchor | Experimental | Device: Brow LiftUse of ZiftLift Tissue Anchors for Brow Lift |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide informed consent to the treatment
- Willing and able to participate in all the required follow-ups
- Over 18 years of age
- Under 75 years of age
- Brow ptosis and/or functional limitations such as vision defects due to tissue laxity caused by aging
Key exclusion criteria (14 listed)
- Known allergies to local anesthesia
- Currently undergoing chemotherapy or radiation therapy for cancer
- Known advanced osteoporosis that may lead to skull thinning
- Taking long-term immunosuppressant therapy
- Taking chronic anticoagulation therapy (including ASA and NSAIDS) which can't be stopped for 10 days before treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brow LiftAlso: Brow PexyMinimally Invasive Brow Lift | Device | ZiftLift Tissue Anchor |
Primary outcome
Change in Brow Elevation
Time frame: 90 days, 6 months, 1, 2, 3 and 4 years
Change in brow elevation in mm from baseline to 90 days, with long term follow-up out to 4 years
2 secondary outcomes
Patient Satisfaction
Time frame: 90 days, 6 months, 1, 2, 3 and 4 years
Physician Satisfaction
Time frame: 90 days, 6 months, 1, 2, 3 and 4 years
Results and safety
The study was stopped early (reason given: Company no longer exists). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A Hilger, MD principal investigator
Centennial Lakes Surgery Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brow Lift in people with Senile Ptosis, run by Zift, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Company no longer exists). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brow Elevation (time frame: 90 days, 6 months, 1, 2, 3 and 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.